v3.26.1
Note 16 - Segments
 6 Months Ended
Mar. 31, 2026
Notes to Financial Statements  
Segment Reporting [Text Block]

Note 16 - Segments

 

Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the CODM, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s CODM is Mitchell S. Steiner, M.D., our Chairman, President and Chief Executive Officer, who views the Company’s operations as one operating segment, which is focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company does not have revenue, incurs expenses primarily in the U.S., and manages the business activities on a consolidated basis. 

 

The accounting policies of the drug development segment are the same as those described in the summary of significant accounting policies.

 

The CODM assesses performance for the drug development segment and decides how to allocate resources based on net loss that is also reported on the income statement as consolidated net loss. The measure of segment assets is reported on the balance sheet as cash, cash equivalents, and restricted cash. 

 

The Company has not generated any product revenue from continuing operations in the current period and expects to continue to incur significant expenses and operating losses for the foreseeable future as the Company advances its product candidates through all stages of development and clinical trials. As such, the CODM uses cash forecast models in deciding how to invest into the drug development segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.

 

The table below summarizes the significant expense categories regularly reviewed by the CODM for the six months ended March 31, 2026 and 2025:

 

  

Three Months Ended

  

Six Months Ended

 
  

March 31,

  

March 31,

 
  

2026

  

2025

  

2026

  

2025

 

Operating expenses:

                

Research and development

 $3,145,783   3,932,102   4,489,965  $9,648,932 

General and administrative

  4,073,185   5,164,433   8,153,018   10,391,546 

Total operating expenses

  7,218,968   9,096,535   12,642,983   20,040,478 
                 

Other segment items:

                

Gain on sale of ENTADFI® assets

  —   974,303   —   1,669,519 

Gain on extinguishment of debt

  —   —   —   8,624,778 

Change in fair value of equity securities

  3,931,416   —   3,811,338   (349,078)

Other income, net

  195,002   269,839   406,516   432,963 

Net income (loss) from discontinued operations, net of taxes

  351,418   (49,226)  351,418   (7,184,670)
                 

Net loss

 $(2,741,132)  (7,901,619)  (8,073,711) $(16,846,966)

 

The Company is a single operating segment and therefore the measure of segment net loss is the same as consolidated net loss and does not require reconciliation.

 

For the six months ended March 31, 2026 and 2025, net cash used in operating activities was $15.1 million and $19.1 million, respectively. The table below summarizes the significant asset categories regularly reviewed by the CODM as of March 31, 2026 and September 30, 2025:

 

  

2026

  

2025

 
         

Cash, cash equivalents and restricted cash

 $27,596,820  $15,794,562